Recall Z-0401-2021— Merz North America, Inc.
Class II · Ongoing
Class II FDA medical device recall by Merz North America, Inc., initiated 2020-09-30. Product: COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin. Product is packaged in a 1.0cc syringe and packed in a sterile pouch.. Reason: The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study..
- Recalling firm
- Merz North America, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-09-30
- Firm location
- Franksville, WI, United States
Product description
COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin. Product is packaged in a 1.0cc syringe and packed in a sterile pouch.
Reason for recall
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
Data sourced from openFDA. This site is unofficial and independent of the FDA.